Innovative Drug Development: Kalydeco Provides A Paradigm, FDA’s Spielberg Says
By
Brenda Sandburg / Email the Author / “The Pink Sheet” Feb. 20, 2012, Vol. 74, No. 8
Regulatory Update / Word Count: 1241 / Article # 00120220016
Executive Summary
The deputy commissioner detailed the steps involved in getting Vertex’s cystic fibrosis drug rapidly through the approval process and noted that FDA is working on innovative study designs and assessing how to better use diagnostics.
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